Health care innovations and medical technology: reaching the unreached

Health care innovations and medical technology: reaching the unreached

Context setting India ill equipped to meet the growing needs of the population. Brilliance and talent in medicine, engineering & basic sciences has forced the world to look eastwards to seek low cost high quality medical care India the Information Technology hub of the world. Our focus : To understand the practical challenges, the interlinkages, and barriers that have resulted in stunted growth of innovation in med-tech in India To understand the unmet needs in the health landscape and potential bridge that health innovations and medical technologies can provide. To deliberate on appropriate solutions to build a vibrant ecosystem and an enabling environment Larger buy-in of stakeholders Page 2

Health care provisioning levers & stakeholder relationships Demand Side People at large and Patients Regulatory bodies Supply Side Healthcare Service Providers Pharmaceutical sector Med Tech Devices Sector Health Insurance & Financing Media/Civil Society, Industrial/Autonomous bodies Academia Research & Development and Production of skilled manpower Page 3

Med- tech industry in India Segmentation of Indian med-tech market 2013 Indian medical device industry (in US$ billion) Orthopaedic and prosthetic products Others Patient aids 8% 10% 27% Dental products 4% 18% 33% Consumables Diagnostic imaging Medical technology is the utilisation of technology from any walk of life into the field of medicine. 2. 0 2. 0 2 0 0 8 2 0 0 9 2. 4 2 0 1 0 2. 8 3. 0 2 0 1 1 2 0 1 2 3. 7 2 0 1 3 4. 4 2 0 14 E 5. 5 2 0 15 E 6. 7 2 0 16 E 7. 9 2 0 17 E 9. 4 2 0 18 E Indian medical devices market is among the top-20 in the world, Fourth-largest medical device industry in Asia after Japan, China and South Korea. The Indian industry was valued at US$3.65 billion in 2013, growing at a CAGR of 12.1% for 2008 2013. The industry is forecasted to reach US$9.4 billion by 2018. Catering to 20% of the world s population, impacting global disease burden significantly, and having been one of the leading producer of low cost reengineered drug markets of the world our role in the medical devices market should have been much more significant. Page 4

Geo political situation and the local manufacturing market Leading suppliers by product area and geography, 2012 (US$ million) Product areas US Germany China Japan Ireland EU-27 Consumables 64.8 28.5 35.6 19.2 20.8 90.6 Diagnostic imaging 232.6 97.7 146.9 78.3 2.2 241.5 Dental products 13.9 14.8 13.7 4.3 1.08 29.8 Orthopedic products 89.47 16.5 17.56 2.5 30.4 63.6 Patient Aids 73.6 19.3 28.4 3.47 64.1 126.6 Ot hers 186.4 176.9 81.6 49.0 4.0 271.7 Total 661.0 353.9 323.9 157.0 122.7 823.8 %age share 27.1 14.5 13.3 6.4 5.0 33.7 Med-tech market is largely based on imports, primarily refurbished market contributing close to 75% of the market. Imports in India are grown from US$1.3 bn in 2007 to US$2.4 bn in 2012 and the exports have stagnated Calls for a focused approach to address the medical device market Page 5

The innovation life cycle Ideation Innovation & design Adoption Go to Market Concept identification Need assessment Understanding the market Product design Lab testing Clinical trial Fulfilling regulatory requirements Fulfilling IP requirements Engaging with manufacturers Successful use of product by end user Page 6

Challenges & barriers Page 7

What have we done until date Recognized med-tech as a separate segment Laid foundation for institutionalization of innovation SIB collaboration with academia internationally--seeding ideas, understanding innovation BIRAC Section 25 co single window for emerging bio-tech industries to enhance strategic research and innovation Millennium Alliance under the leadership of FICCI in partnership with USAID network to bring the actors together to scale innovation CAMTech India-Jugaadthon ideate and co-create, recognize innovation Page 8 Presentation title

Challenges: Regulatory & institutional framework Regulatory and institutional framework Ideation and concept Innovations and design Adoption Go to market Lack of med-tech focused regulation that feeds into national health policy State-level variations in import regulation Lack of a single window for all legal compliances Absence of structured FDI policy Lack of med tech SEZs and innovation parks Lack of preferential imports for raw material over finished products Overdone licensing complete renewal for every small incremental improvement Lack of a separate central regulatory body to certify medical devices Mandatory clinical trials even for FDA approved products Transparent and structured procedure for adoption Lack of Risk-based categorisation Lack of tax breaks to encourage indigenous manufacturing No preferential imports for raw material over finished products Lack of role clarity, considerable overlap between ministries (Health, commerce, drug) w.r.t current regulation regime Bureaucratic hassles perceived and real Absence of indigenous centralised certification programs to validate marketable products Page 9 Presentation title

Challenges: Social & physical infrastructure to promote innovation and R&D Social and physical infrastructure to promote innovation and R&D Ideation and concept Innovations and design Adoption Go to market Lack of institutional mechanism under cross sectoral mentorship to ensure cohesiveness of teams Few need identification and assessments undertaken Lack of proper hospital infrastructure Absence of a prototype super-marts Few med tech incubation centres, R&D labs Constrained technology development and translation--valley of Death Poor service quality in health facilities deters adoption Absence of validation by user experts Rising cost of validationclinical trials of FDA approved products Lack of involvement of manufacturers during ideation Absence of an ancillary ecosystem - multi layered, multi skilled capacity conducive for creation of med-tech design environment. Lack of stimulus to trigger scientific acumen Page 10 Presentation title

Challenges: Lack of Funding Funding Ideation and concept Innovations and design Adoption Go to market Rarely available early stage funding or angel funding to encourage young innovators. Constrained funding for incremental innovations Lack of coordination between funding agencies Ill-structured financing and reimbursements mechanismspiecemeal approach Lack of adequate documentation of adverse reaction to offer requisite comfort to certifying and funding agency Reduced governmental participation Complex procedures on government funding Reduced adoption High capital costs. Absence of incentives to encourage local manufacturers. Lack of institutional arrangement to create a base for export. Page 11 Presentation title

Challenges: Lack of collaboration, knowledge sharing and mentorship programmes Collaboration knowledge sharing and mentorship programme Ideation and concept Innovations and design Adoption Go to market Far and few institutionalized national and international collaboration embrace innovation to facilitate innovation and entrepreneurship Absence a knowledge mine and platform to discuss success, failures and lessons learnt Need for greater dialogue between innovators and manufacturers at proof of concept stage. Lack of awareness, dialogue, collaboration between key stakeholders to understand challenges around adoption Lack of industry dialogue to share technology that can be used in health care. Far and few institutional mechanisms for MNCs to adopt innovators and design teams Absence of an autonomous body for mentorship across all stages of innovation. Lack of collaboration between stakeholders to co-create an environment of combination science Lack of sharing platform and forum to discuss case studies on innovations that worked and why, which failed Page 12 Presentation title

Recommendations Page 13 Presentation title

Creation of a sustainable ecosystem The need for a sustainable ecosystem clearly emerges as the solution to nurture innovation, uphold patient safety, in our efforts to offer comprehensive continuum of care provided; thus ensuring accessible, affordable high quality care through medtech innovation. Page 14

Strong regulatory environment Create an autonomous regulatory body with collaborative controllers Appropriately qualified regulatory personnels. Rationalising med-tech approval process to make innovations a commercial success. Provide a robust framework for IP laws to protect innovators interest. Risk based regulation thus eliminating the need to enlist devices. Indian Regulatory framework Support R&D and innovative initiatives by providing tax breaks and funds Independent regulation for medical devices outside the Drugs & cosmetic Act, 1940 Page 15

Strong institutional framework I nn o va t o r Autonomous regulatory body Early stage of innovation: Is directed by regulatory body to appropriate incubation center based on the kind of innovation I nn o va t i o n s Regulatory requirement for registration/ certification based on risk categorization Adoption stage of innovation: Based on Risk categorization, different risk certification shall be awarded Quality Assurance team (Independent) Quality Control team (Independent) Empanelled Technology incubation centers - Mentorship programmes Empanelled Experts Experts: Multi disciplinary Page 16

Co-creation through combination science Creation of a skilled talent pool that is multidisciplinary and multi- layered. An ancillary ecosystem should be simultaneously developed. Creation of a knowledge platform to share knowledge around innovation, its processes, licensing, manufacturing, marketing, advocacy and adoption. Create platform for presenting innovative products to public through trade fares. Incentivize innovation and glamorize innovators to promote innovation Page 17

Breaking market barriers and market expansion of med tech manufacturing Distribution Networks Position the domestic healthcare infrastructure to drive demand for affordable quality technology products. Revolutionising technology: Need to position India as the hub of frugal innovation and focus on exporting these devices to the developing world. Commercial viability of device Linking the Innovators to the market Value Addition to user Integrate innovation and growth of med-tech industry with the forth coming Health policy to catalyse the systematic uptake of med-tech innovations Setting up SEZs to boost local manufacturers and prototype firms to reduce cost of manufacturing Evidence based research and funding. Interfacing & networking Product design Page 18

Collaboration with stakeholders globally Vibrant ecosystem to promote growth of medical technology industry in India and ensure affordable Industry bodies India - Market needs Innovation Ecosystem Government Regulators Manufacturers Accessible and high quality health care Technologist Innovator: Ideation Innovation Entrepreneurship Clinicians Funders, Donors, Venture Capitalist, Angel networks Capacity Co-creation Global - Market needs Page 19 Presentation title

Thank you Page 20 Presentation title